Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Cooper Health System
• Treatments: Indomethacin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1 Subjects who are undergoing endoscopic retrograde cholangiopancreatography (ERCP)

• Age > 18 years

• Non-pregnant

• Non-prisoners

• Subjects who can sign informed consent

• Serum Creatinine < 1.2 milligrams/deciliter (mg/dL)

• Subjects without renal failure (acute or chronic)

• Subjects without congestive heart failure (ejection fraction < 40%)

• Subjects without cirrhosis of the liver

• Subjects without allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)

• Subjects not on non-steroidal anti-inflammatory drugs NSAIDS prior to enrollment

Exclusion Criteria:

• Subjects who are not undergoing ERCP

• Age < 18 years

• Pregnancy

• Prisoners

• Subjects lacking the capacity to consent for themselves

• Serum Creatinine > 1.2 milligrams/deciliter (mg/dL)

• Subjects with renal failure (acute and chronic)

• Subjects with congestive heart failure (ejection fraction < 40%)

• Subjects with cirrhosis of the liver

• Subjects with allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)

• Subjects with gastrointestinal hemorrhage

• Subjects on chronic non-steroidal anti-inflammatory drugs NSAIDS

• Subjects with acute pancreatitis the day of their procedure (CITE 1-3)(APPENDIX 1)